Palisade Bio, Inc. - PALI STOCK NEWS

Palisade Bio (Nasdaq: PALI) has made significant progress towards launching its Phase 1 human clinical study for PALI-2108, a locally activated PDE4 inhibitor prodrug for treating ulcerative colitis (UC). The company has:

1. Completed nonclinical safety and toxicity studies
2. Finalized Phase 1 clinical trial design
3. Established Maximum Recommended Starting Dose
4. Completed pre-Clinical Trial Application (CTA) meeting with Health Canada
5. Submitted the CTA for the Phase 1 study

The Phase 1 study will be a single-center, double-blind, placebo-controlled study focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients. Palisade Bio plans to enroll approximately 90 patients across various cohorts and remains on track to initiate the study before year-end.

Palisade Bio (Nasdaq: PALI) has launched a new corporate branding and website, reaffirming its commitment to developing next-generation precision therapies for autoimmune, inflammatory, and fibrotic diseases. The company's lead program, PALI-2108, targets moderate-to-severe ulcerative colitis and is advancing towards a Phase 1 clinical study before year-end. Palisade Bio plans to use advanced machine learning to identify patients with elevated PDE4 activity, potentially enhancing treatment efficacy. The company is also developing PALI-1908 for fibro stenotic Crohn's Disease. CEO J.D. Finley expressed confidence in the company's progress and upcoming milestones, emphasizing the potential to address significant unmet medical needs in established commercial markets.

Palisade Bio (Nasdaq: PALI) has reported promising data on PDE4B expression as a potential marker for patient stratification in Ulcerative Colitis (UC) treatment. The company's analysis, conducted in collaboration with Strand Life Sciences, revealed that 70% of adult colitis patients and 90% of pediatric colitis patients show PDE4B expression above a specific threshold. This finding could significantly improve patient selection for targeted therapies.

Palisade is advancing its lead program PALI-2108, an oral colon-specific PDE4 inhibitor prodrug for UC treatment. A Phase 1 clinical study is set to begin before year-end. Preclinical studies in a DSS-induced UC mouse model demonstrated PALI-2108's potential efficacy, showing reduced PDE4B expression, increased cAMP levels, and decreased inflammatory markers with increasing doses.

Palisade Bio (Nasdaq: PALI), a biopharmaceutical company focusing on autoimmune, inflammatory, and fibrotic diseases, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company's Compensation Committee approved an option grant for 5,000 shares of common stock to Joerg Heyer, the new Head of Translational Science and Medicine, as a material inducement to employment.

The option, issued on August 16, 2024, has an exercise price of $3.94, matching the closing price of Palisade's common stock on the grant date. The option will vest quarterly over three years, contingent on Mr. Heyer's continued service to the company.

Palisade Bio (Nasdaq: PALI) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Progress towards Phase 1 clinical study of PALI-2108 for Ulcerative Colitis (UC) before year-end
2. Completed microbiome study and nonclinical IND/CTA-enabling studies
3. Expanded global IP portfolio with European patent grant
4. Completed first GMP batch of PALI-2108
5. Advanced collaboration with Strand Life Sciences on PDE4-related biomarkers
6. Received Canadian patent allowance for PALI-2108

Financial results: $11.4M cash on hand, sufficient through Q1 2025. Net loss of $4.1M, up from $3.4M in Q2 2023. R&D expenses increased 21% to $2.6M, while G&A expenses rose 11% to $1.6M.

Palisade Bio (Nasdaq: PALI) has announced progress in developing PALI-2108, its lead drug candidate for Ulcerative Colitis (UC). The company has determined the Maximum Recommended Starting Dose (MRSD) for human trials using comprehensive scaling approaches and modeling. Key findings from pharmacokinetic (PK) modeling and simulations indicate that dosing regimens with minimal accumulation are both safe and within the doses showing maximal efficacy in animal models. Palisade Bio has established dose levels and trial design for PALI-2108, an orally administered, colon-specific PDE4 inhibitor prodrug. The upcoming Phase 1 clinical trial, set to commence before year-end, will evaluate safety, tolerability, and PK in healthy volunteers and UC patients, as well as pharmacodynamics in UC patients.

Palisade Bio (Nasdaq: PALI) has released a Virtual Investor 'What This Means' segment featuring Chief Medical Officer Mitchell Jones, MD, PhD. The segment focuses on the company's recent microbiome study that confirmed bacterial enzymes for local bioactivation of their lead product candidate, PALI-2108. This development is significant for Palisade Bio's planned Phase 1 human clinical study for the treatment of Ulcerative Colitis.

The company, which specializes in developing therapeutics for autoimmune, inflammatory, and fibrotic diseases, views this as an important step forward in their research. The Virtual Investor segment is now available online, providing investors and interested parties with insights into the implications of this study for Palisade Bio's future clinical trials and potential treatment options.

Palisade Bio (Nasdaq: PALI) has successfully completed a microbiome study for its lead product candidate, PALI-2108, aimed at treating Ulcerative Colitis (UC). The study confirmed that beta-glucuronidase, an enzyme important for the bioactivation of PALI-2108, is present at similar levels in mouse, dog, and human microbiota, including healthy humans and those with Crohn's disease and UC.

Key findings include:

• Beta-glucuronidase presence is not significantly different among species or between healthy and diseased human cohorts
• The study supports previous findings of adequate bioactivation of PALI-2108 in Normal Healthy Volunteers and UC patients' stool
• Palisade Bio is advancing towards a Phase 1 clinical study of PALI-2108 for UC treatment, expected to begin before the end of 2024

Palisade Bio (Nasdaq: PALI) announced that the European Patent Office has issued a decision to grant notice for patent number 4,157,853, titled 'Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.' This patent, expected to be issued on July 31, 2024, includes composition of matter claims for PALI-2108 and PALI-1908, providing coverage beyond 2042. PALI-2108 is being developed for moderate-to-severe Ulcerative Colitis, while PALI-1908 targets fibro stenotic Crohn's Disease.

The patent claims cover PALI-2108's proprietary composition, designed as an orally administered, colon-specific PDE4 inhibitor prodrug. Its unique galactose-derived sugar moiety allows for minimal absorption until cleaved by colonic bacteria, ensuring localized bioactivation. Palisade Bio plans to initiate a Phase 1 clinical study for PALI-2108 before the end of 2024.